In response to growing client demand, and based on recently-established international biosafety regulations, World Courier has begun rolling out dedicated storage areas for GMO-derived pharmaceutical products throughout its global investigational drug storage network.

“We believe that biotechnology will play an important role in the future of pharmaceutical research and development, and have chosen once again to assert our position as the market leader in providing critical services to the pharmaceutical sector,” says Carlos Jankowski, global executive director of World Courier’s Clinical Trial Supply Chain Services (CTSCS) division. “As countries begin to regulate the handling of GMOs and GMO-derived products, we will be ready to offer up-to-the-minute validated facilities that comply specifically with national regulations governing the storage and distribution of these products.”

GMO storage capabilities are now available at company depots in Buenos Aires (Argentina), Sao Paulo (Brazil) and Santiago (Chile), with Bangalore (India), México City (México) and Bogotá (Colombia) expected to come online by year-end. GMO facilities in Beijing (China), Moscow (Russia) and Lima (Peru) will be developed as client demand requires.

World Courier’s new GMO storage units are equipped with qualified ultra freezers (-80°C), contact freezers (-20°C) and, in some countries, with controlled ambient temperature areas (15°C to 25°C). These dedicated storage areas have been established in accordance with local biosafety requirements and are used primarily to house biosafety level (BSL) 1 and 2 products – those most readily used in trials. Special SOPs and safety measures have been implemented for GMO storage units, which have been carefully isolated from other product storage areas to eliminate all possibilities of cross-contamination.

About GMOs

The term ‘genetically modified organism’ (GMO) refers to biological organisms whose genetic material has been modified or altered via non-natural methods. Using genetic engineering techniques, undesirable characteristics within the organism are altered or eliminated, or new characteristics are introduced. GMO applications are now widespread, beginning with agricultural practice where crops may be modified to increase production, or resist herbicides or vermin. In the medical field, many drugs and pharmaceutical products, such as insulin, are now similarly produced using this technology. Gene therapy research, the most advanced form of genetic modification, offers much hope in finding cures to debilitating and life-threatening diseases. Some 100 gene therapy clinical trials are now initiated annually in an area that is expected to grow over time.

In response to safety concerns associated with GMOs, four biosafety levels (BSL) have been established to govern all combinations of laboratory practices and techniques, safety equipment and facility management. Each biosafety level calls for successively more restrictive practices and facilities as materials move from the least restrictive BSL1 to the highest hazard level of BSL4.